Sherman RE - Search Results

1

Accelerating development of scientific evidence for medical products within the existing US regulatory framework.

Sherman RE, Davies KM, Robb MA, Hunter NL, Califf RM. Sherman RE, et al. Nat Rev Drug Discov. 2017 May;16(5):297-298. doi: 10.1038/nrd.2017.25. Epub 2017 Feb 24. Nat Rev Drug Discov. 2017. PMID: 28232726

2

The Food and Drug Administration and pragmatic clinical trials of marketed medical products.

Anderson ML, Griffin J, Goldkind SF, Zeitler EP, Wing L, Al-Khatib SM, Sherman RE. Anderson ML, et al. Among authors: sherman re. Clin Trials. 2015 Oct;12(5):511-9. doi: 10.1177/1740774515597700. Epub 2015 Sep 15. Clin Trials. 2015. PMID: 26374684 Free PMC article.

3

Independent data monitoring committees: preparing a path for the future.

Hess CN, Roe MT, Gibson CM, Temple RJ, Pencina MJ, Zarin DA, Anstrom KJ, Alexander JH, Sherman RE, Fiedorek FT, Mahaffey KW, Lee KL, Chow SC, Armstrong PW, Califf RM. Hess CN, et al. Among authors: sherman re. Am Heart J. 2014 Aug;168(2):135-41.e1. doi: 10.1016/j.ahj.2014.05.003. Epub 2014 May 15. Am Heart J. 2014. PMID: 25066551 Free PMC article.

4

Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.

Sacks LV, Shamsuddin HH, Yasinskaya YI, Bouri K, Lanthier ML, Sherman RE. Sacks LV, et al. Among authors: sherman re. JAMA. 2014 Jan 22-29;311(4):378-84. doi: 10.1001/jama.2013.282542. JAMA. 2014. PMID: 24449316

5

The FDA Sentinel Initiative - An Evolving National Resource.

Platt R, Brown JS, Robb M, McClellan M, Ball R, Nguyen MD, Sherman RE. Platt R, et al. Among authors: sherman re. N Engl J Med. 2018 Nov 29;379(22):2091-2093. doi: 10.1056/NEJMp1809643. N Engl J Med. 2018. PMID: 30485777 No abstract available.

6

Flexibility in the FDA approach to orphan drug development.

Hunter NL, Rao GR, Sherman RE. Hunter NL, et al. Among authors: sherman re. Nat Rev Drug Discov. 2017 Nov;16(11):737-738. doi: 10.1038/nrd.2017.151. Epub 2017 Sep 1. Nat Rev Drug Discov. 2017. PMID: 28860647 No abstract available.

7

Combination products: modernizing the regulatory paradigm.

Hunter NL, Sherman RE. Hunter NL, et al. Among authors: sherman re. Nat Rev Drug Discov. 2017 Aug;16(8):513-514. doi: 10.1038/nrd.2017.66. Epub 2017 May 12. Nat Rev Drug Discov. 2017. PMID: 28496147

8

Real-World Evidence - What Is It and What Can It Tell Us?

Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, LaVange L, Marinac-Dabic D, Marks PW, Robb MA, Shuren J, Temple R, Woodcock J, Yue LQ, Califf RM. Sherman RE, et al. N Engl J Med. 2016 Dec 8;375(23):2293-2297. doi: 10.1056/NEJMsb1609216. N Engl J Med. 2016. PMID: 27959688 No abstract available.

9

Knowing When and How to Use Medical Products: A Shared Responsibility for the FDA and CMS.

Califf RM, Sherman RE, Slavitt A. Califf RM, et al. Among authors: sherman re. JAMA. 2016 Dec 20;316(23):2485-2486. doi: 10.1001/jama.2016.16734. JAMA. 2016. PMID: 27820637 No abstract available.

10

Expediting drug development--the FDA's new "breakthrough therapy" designation.

Sherman RE, Li J, Shapley S, Robb M, Woodcock J. Sherman RE, et al. N Engl J Med. 2013 Nov 14;369(20):1877-80. doi: 10.1056/NEJMp1311439. N Engl J Med. 2013. PMID: 24224621

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